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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL DISPOSABLE TEMPERATURE PROBE-72; HUMIDIFIER, RESPIRATORY GAS, (
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TELEFLEX MEDICAL DISPOSABLE TEMPERATURE PROBE-72; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 872-DTP
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The lot number was not reported; therefore a device history record review was performed based on a potential lot number from the sales history of the customer.No relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer complaint alleges "the temperature probe would not read temp appropriately".The issue was discovered when the temperature probe was hooked up to the heater during patient use.No patient harm reported.When a different device was used, the temperature displayed correctly.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.Upon receipt the disposable temperature probe set was visually inspected for any signs of abuse/misuse/damage.Nothing was noted.Functional testing was performed and the disposable temperature probe set was incorporated into a standard neptune bench test setup.The neptune was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, a 382-10 universal water column, and an 872-dtp deposable temperature probe was connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests and was functioning real time.The neptune test parameters were set as follows: operational mode was set to invasive, heated gas was set at 37 c, rainout was set to full scale to the right (heavy rainout).The unit, to include operation of the disposable temperature probe set, functioned without any interruption or functional anomalies for ~2.0 hours.The device history record of batch number 74l1900999 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-con formance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint could not be confirmed.
 
Event Description
Customer complaint alleges "the temperature probe would not read temp appropriately".The issue was discovered when the temperature probe was hooked up to the heater during patient use.No patient harm reported.When a different device was used, the temperature displayed correctly.
 
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Brand Name
DISPOSABLE TEMPERATURE PROBE-72
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9535053
MDR Text Key198507148
Report Number3004365956-2019-00376
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K063758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number872-DTP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received01/15/2020
Supplement Dates FDA Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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